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Author Affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.
Randomized controlled trials (RCTs) are considered the most robust source of scientific evidence to inform the medical community about the benefits and risks of therapeutic interventions. In recommendations for practitioners, treatment guidelines recognize the special value of RCTs by designating such studies as the highest level of evidence in assessing the efficacy of various therapeutic strategies. However, despite the acknowledged importance of RCTs, all randomized trials are not equivalent in reliability, credibility, and value. Every trial has limitations that can compromise the study's interpretability and undermine the strength of its conclusions. In extreme cases, a poor-quality RCT can lead to important patient and societal harms.1,2
Nissen SE. Concerns About Reliability in the Trial to Assess Chelation Therapy (TACT). JAMA. 2013;309(12):1293–1294. doi:10.1001/jama.2013.2778
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